These days, millions are are turning to digital health solutions, some of which can reportedly help manage diabetes, improve sleep, monitor heart health, encourage weight loss and track whether patients are sticking to regimens, as noted by The Wall Street Journal. In fact, after the health scare, government and healthcare systems around the world are now beginning to realize just how essential digital health has become, in addition to the role it plays in providing higher quality, easily accessible, and affordable care, as noted by Forbes. That’s where a company, like AI/ML Innovations (CSE:AIML)(OTC:AIMLF) and its Health Gauge subsidiary, a leading digital health solutions provider, may be able to help.
At the moment, Health Gauge, has partnered with the University of Alberta’s ST Innovations regarding Neural Network data set validation work in support of Health Gauge’s FDA 510k and Health Canada submission processes for clearance as a Class 2 medical device. Along with AI/ML Innovations, other top companies to watch include PharmaTher Holdings Ltd. (CSE:PHRM)(OTC:PHRRF), Apyx Medical Corporation (NASDAQ:APYX), Empower Clinics Inc. (CSE:CBDT)(OTC:EPWCF), and Reliq Health Technologies Inc. (TSXV:RHT)(OTC:RQHTF).
AI/ML’s Health Gauge One Step Closer to FDA510k Medical Device Clearance
AI/ML Innovations Inc. (CSE:AIML)(OTCQB:AIMLF), a company committed to acquiring and advancing Artificial Intelligence/Machine Learning technologies that address urgent societal needs, is pleased to announce that its subsidiary, Health Gauge, has partnered with the University of Alberta’s ST Innovations regarding Neural Network data set validation work in support of Health Gauge’s FDA 510k and Health Canada submission processes for clearance as a Class 2 medical device. Additionally, this collaboration is designed to help refine and optimize the overall accuracy of Health Gauge’s latest wearable device (smart watch), The Phoenix, for blood pressure (BP), O2, and other predictive data relating to a patient’s physiological information.
The workflow process with ST Innovations is designed to enhance Health Gauge’s data sets for artificial intelligence training by monitoring a number of research volunteers, with the primary objective of the study being the validation of The Phoenix against conventional data collection methods for blood pressure (cuff), photoplethysmography (PPG), spO2, heart rate using a single‐lead ECG, and systemic temperature using an ear thermometer.
“This is significant work in that it helps create an even more robust and intuitive product,” said Randy Duguay, CEO of Health Gauge. “An aggregated data set is the foundation for our AI/ML platform, as there is a direct correlation between an increase in the number of data sets and improved accuracy of the product, which benefits our HG Phoenix customers and enhances the possibility for improved health outcomes.”
ST Innovations, the business arm of the University of Alberta’s SMART Network, is Alberta’s leading R&D services organization, connecting entrepreneurs with world-class researchers in support of the latest innovation and R&D. Combining a leading research network, specialized equipment and market insights, ST Innovations is a health technology development center focused on accelerating innovative health ideas at every stage by providing customized services which identify and remove barriers to the health innovation development process.
Other related developments from around the markets include:
PharmaTher Holdings Ltd., a clinical-stage psychedelics biotech company, is pleased to announce that it has filed a pre-Investigational New Drug meeting request and complete pre-IND briefing package with the U.S. Food and Drug Administration to support the clinical development of KETABET™ and the proposed Phase 2 clinical study as a potential next-generation treatment for depression, and to discuss the product development plan for the Company’s patented hydrogel-forming microneedle patch delivery technology.
Apyx Medical Corporation, a maker of medical devices and supplies and the developer of Helium Plasma Technology, marketed and sold as Renuvion® in the cosmetic surgery market and J-Plasma® in the hospital surgical market, today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (“FDA”), which is intended to obtain a specific clinical indication for the use of Renuvion in dermal resurfacing procedures. “Following the recent completion of our U.S. IDE clinical study evaluating the use of our Renuvion technology in dermal resurfacing procedures, we were pleased to submit our 510(k) premarket notification for this procedure category on May 28th,” said Charlie Goodwin, President and Chief Executive Officer. “This submission is an important milestone that underscores our continued progress in pursuing specific clinical indications to market and sell Renuvion for target procedures in the cosmetic surgery market. I would like to thank our clinical and regulatory teams for their exceptional efforts which has made our recent progress possible, and look forward to the FDA’s review of our submission.”
Empower Clinics Inc. announced the signing of six Letters of Intent (LOI’s) to open medical healthcare centers with REXALL/PHARMA PLUS PHARMACIES LTD the second largest pharmacy group in Canada. It is proposed that Empower will act as a subtenant for these initial six locations to build and operate health care centers as a key driver of Empower’s national clinic expansion strategy. Services include full primary care led by medical doctors plus paramedical services with practitioners providing services including chiropractic care, physiotherapy and more. Beneficiaries of these services include the pharmacies large existing customer base in addition to patients in the wider communities each location will serve.
Reliq Health Technologies Inc., a rapidly growing global telemedicine company that develops innovative Virtual Care solutions for the multi-billion-dollar Healthcare market, announced that it has resumed onboarding with Rural Health Clinics and Federally Qualified Health Centers thanks to the significantly reduced COVID numbers in the US.
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